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Curis may proceed with CUDC-427 trial
The FDA completes its review of Curis' (CRIS) CRL response to the partial clinical hold on its anti-cancer agent CUDC-427. The agency determines that it is safe to proceed.
The phase 1 study on patients with solid tumors was placed on partial clinical hold in November after one patient died due to liver failure one month after discontinuing the drug. No new patients could be enrolled until Curis submitted data and analyses on all treated patients plus a protocol amendment.
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